The <scp>ILEOSTIM</scp> trial: A multicentre randomised controlled trial evaluating the impact of efferent loop stimulation prior to ileostomy reversal on postoperative ileus

BACKGROUND: Strategies to optimise bowel function before stoma reversal surgery (SRS) are needed to improve postoperative outcomes. Efferent bowel stimulation (EBS) prior to stoma closure has been proposed as a potential strategy to reduce postoperative ileus (POI) incidence and improve the patient's postoperative course. METHODS: A multicentre randomised controlled trial was designed to evaluate the effectiveness of pre-SRS EBS in reducing POI incidence. Patients scheduled for elective SRS were randomised 1:1 to either an intervention group, receiving daily EBS with saline and a nutritional thickener for 2 weeks preoperatively, or a control group, undergoing SRS without stimulation. The primary endpoint was POI incidence. Secondary outcomes included the time to oral diet tolerance, passage of first flatus/stool, surgery-related comorbidities, length of hospital stay and incidence of Low Anterior Resection Syndrome (LARS) (NCT05302557-31/03/2022). RESULTS: From June 2021 to April 2023, 175 patients were enrolled from 18 hospitals in Spain, 78 (44.5%) and 97 (55.4%) of whom were allocated to the intervention and control groups, respectively. We found that EBS was not significantly associated with a decrease in POI incidence (7.6% vs. 16.4%, p = 0.088). No significant differences in the median hospital stay (p = 0.545) or LARS at discharge (p = 0.087) were observed between the two groups. The EBS group showed fewer but more severe complications (p = 0.015). CONCLUSION: Preoperative EBS is a feasible and reproducible intervention that may represent a potential strategy to reduce POI following SRS.